Core Outcome Measures in Effectiveness Trials

Development of a provisional core domain set for polymyalgia rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

General Information

Abstract:
Objective.

The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review.

Methods.

A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress.

Results.

Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR.

Conclusion.

A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.

Aim:
To develop a core set of outcome measures to be used in clinical trials for PMR

Authors:
Toby Helliwell, Elisabeth Brouwer, Colin T. Pease, Rodney Hughes, Catherine L. Hill, Lorna M. Neill, Serena Halls, Lee S. Simon, Christian D. Mallen, Maarten Boers, John R. Kirwan and Sarah L. Mackie

Publication

Journal:
The Journal of Rheumatology
Volume:
43
Issue:
1
Pages:
-
Year:
2016
DOI:
Further Study Information

Date:
Funding source(s):
Sponsor: National Institute for Health Research (NIHR.) Dr. Mackie is funded by a Clinician Scientist Fellowship from the National Institute for Health Research.

Health Area

Disease Category
Rheumatology

Disease Name
Polymyalgia rheumatica

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Literature review

Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research
COS for practice

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